LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K183471
    Device Name
    IC-WHCD100 (Inspire)
    Manufacturer
    Good Doctors Co.,Ltd.
    Date Cleared
    2020-07-02

    (566 days)

    Product Code
    NBL
    Regulation Number
    872.1745
    Why did this record match?
    Applicant Name (Manufacturer) :

    Good Doctors Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The IC-WHCD100 (Inspire) is intended to be used as an aid in the detection and diagnosis of dental caries.
    Device Description
    The IC-WHCD100 is a toothbrush-sized handpiece used for diagnosis of caries. A USB cable is used to connect the handpiece to a personal computer with a dental imaging software. After a camera cover is placed over the end, the handpiece is positioned over the tooth to be examined. The camera takes images by illuminating the tooth surface with a white LED light for regular tooth image. With fluoresced light, the device can show bacteria on the surface of tooth. With infrared light, the device can show tooth cavity by highlighting enamel. The user can view the images on 510k cleared dental imaging software such as Apteryx vision (k983111), Romexis (K171385), Sidexis (K132773), etc.
    Ask a Question
    K Number
    K173157
    Device Name
    Dr's Light2
    Manufacturer
    Good Doctors Co.,Ltd.
    Date Cleared
    2018-05-29

    (242 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Good Doctors Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dr's Light 2 is a hand held LED polymerization light intended to cure dental composites using visible light.
    Device Description
    Not Found
    Ask a Question
    K Number
    K171867
    Device Name
    Dr’s Finder NEO
    Manufacturer
    Good Doctors Co.,Ltd.
    Date Cleared
    2018-03-30

    (281 days)

    Product Code
    LQY, LOY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    Good Doctors Co.,Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dr's Finder NEO is intended for detecting the apex of root canal.
    Device Description
    The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
    Ask a Question

    Page 1 of 1